科伦博泰生物-B2023年年度报告

24645578891113163168169170172174175239240 108 666 3485 • H 183171712-1716 H06990 https: //kelun-biotech.com 2023A166®HER2-ADC)A140®SKB264®MK-2870TROP2-ADC(CDE)6CDE8 FDAICH 20233SKB264(MK-2870)EllipsesA400(EP0031)FDA ADC(RDC) 20237112022IPO2023IPO 2024IND 2023 •SKB264/MK-2870 oTNBCTNBC320238SKB264 (MK-2870)TNBC3 202312SKB264 (MK-2870)1TNBCNDA202311NDA 2023126SKB264 (MK-2870)TNBC22023SABCSSKB264ORR42.4%DCR76.3%PFS5.7OS16.8 20243SKB264 (MK-2870)PD-L1TNBC1LTNBC3 oHR+/HER2-BC20236SKB264 (MK-2870)HR+/HER2-BC2L+HR+/HER2-BC3 20239SKB264 (MK-2870)KL-A167PD-L1INDHR+/HER2-BC 20231022SKB264 (MK-2870)HR+/HER2-BC1/22023ESMOSKB264 (MK-2870)SKB264ORR36.8%DCR 89.5%PFS11.1 oEGFRNSCLC20231SKB264 (MK-2870)EGFR-TKIEGFRNSCLC 20237EGFRNSCLCTKISKB264 (MK-2870)3 2023642023ASCOSKB264 (MK-2870)NSCLC2SKB264 (MK-2870)TKIEGFRNSCLC50%1LSKB264(MK-2870)ORR 60.0%DCR 100%PFS11.1 oEGFRNSCLCSKB264 (MK-2870)A167EGFRNSCLC2 2023EGFRPD-(L)12ASCOSKB264 (MK-2870)ORR26%DCR 89%PFS5.3 •A166 oA1663L+HER2+ BC220235NDAo2L+HER2+ BC320236 ADC oSKB315/MK-1200SKB3151a1/2 oSKB410/MK-312020232SKB410IND1aoSKB501IND2024 • oA167A1671LRM-NPC3oA140A140RASmCRCHNSCC NDA20239oA40020237RET+ NSCLC 202365RETA40012023ASCOA4001L2L+RET+ NSCLCORR80.8%69.7%DCR96% 202311A400FDARET20243A400FDARETNSCLC • oA223RA2AA2oA277(CKD-aP)2oSKB3781oSKB3361oA2961 •BCNSCLCGI • oADC(1)SKB264 (MK-2870)(2)SKB315(3)ADCADCADC (1)ADC20233175.01,205.5(3)(2)20231030.0215.3(4)SKB264 (MK-2870)(3) 20233SKB264 (MK-2870)EGFRNSCLCECPD-L150%NSCLCNSCLCEC75.0532.9(5)2024 20231100.0677.0(6)B (3)202333016.8886(4)2023103117.1779(5)20243117.1059(6)202312016.7702 oEllipsesEllipsesEllipsesA400EllipsesA400EP0031 A400/EP0031202328920231231A400/EP003117202311A400/EP0031FDARET20243A400/EP0031FDARETNSCLC o20239TBM-001TBM-001 •20237111,258.91,155.7(7)202388196179.7(8) 202371110.91803 (8)20238810.91663 I. (ADC)SKB264A166SKB264NDATROP2 ADCA166HER2(HER2+)NDAHER2 ADC10 TNBCBCNSCLCNPCGCOCSCLCUCHNSCCECCCCRPCCRCMTC 120243SKB264PD-L1TNBC 220236SKB264HR+/HER2– BC TNBCBCNSCLCNPCGCOCSCLCUCHNSCCECCCCRPCCRCMTC 1 22CRCHNSCC ADCADCADCADCOptiDC(cGMP) ADCADCSKB264SKB315SKB410ADCADCEllipsesHarbour BioMed (BC)(NSCLC)(GI)(GC)(CRC)NDA2024INDADCADC •ADC oSKB264 (MK-2870)TROP2 ADCoA166NDAHER2 ADCHER2+oSKB315 (MK-1200)CLDN18.2 ADCoSKB410 (MK-3120)Nectin-4 ADCoSKB501ADCIND2024 • oA167PD-L1oA140EGFRoA400RETNSCLCMTCRETREToA296(STING)(ICI) SKB264 (MK-2870) SKB2642 (TROP2) ADCTROP2BCNSCLCSKB264TROP2 ADCTROP2 ADCADCADC SKB264I(DAR)7.4pHADC 20225SKB264 (MK-2870)SKB264TROP2 ADCSKB264 SKB264 TNBC20227SKB264TNBC20228TNBC320238SKB2642LTNBC3(PFS)SKB264NDA202311NDANDA20231220243L+TNBC 20243SKB264PD-L1TNBC1LTNBC3 2023(SABCS)TNBC2SKB264(ORR)42.4%(DCR)76.3%(mPFS)5.7(OS)16.8TROP2H≥200 n=32ORR53.1%mPFS5.8OS3(TRAE)≥10%TRAE3TRAE HR+/HER2- BCSKB26420236(HR+)2(HER2-) BC2L+ HR+/HER2-BC320239SKB264KL-A167PD-L1INDHR+/HER2- BC2024(ET)1L HR+/HER2- BC 202310222023(ESMO)SKB264HR+/HER2- BC1/2SKB264ORR36.8%DCR89.5%PFS11.13TRAE≥5%γ-(GGT)TRAE EGFRNSCLCSKB26420231EGFR-TKIEGFR(NSCLC)20237EGFRNSCLCTKI320233L EGFRNSCLC2024NDA 2023ASCOSKB264NSCLC2TKIEGFRNSCLC50%1LSKB26460.0%ORR 100%DCR11.1PFS EGFRNSCLC20223INDEGFRNSCLC2A16720241L EGFRNSCLC 2023EGFRPD-1/L12ASCOSKB264ORR26%DCR 89%PFS5.3 NSCLC3TRAE≥5%TRAE SKB264 (MK-2870)2 SKB264 A166 A166NDAHER2 ADCHER2+BCGIHER2+ BCADC A166(DAR)DARADCA166 A16611bA166HER2+BC2(RP2D)ORR73.9%HER2+ GCORR31.3%A166®Enhertu®®20231231(FDA)HER2 ADCA166(9)A166HER2+ (9)A166®Enhertu®®≥10%34≥2%®®Enhertu®Enhertu®®® A166A1663L+HER2+ BC220235NDA3L+HER2+ BC3A166T-DM12L+HER2+ BC20236HER2+GCCRC1b202420253LHER2+ BC A166 SKB315 (MK-1200) SKB315CLDN18.2 ADCSKB315CLDN18.2ADC CLDN18.2CLDN18.2zolbetuximab20233CLDN18.2CLDN18.2 ADCADCCLDN18.2SKB315CLDN18.2 20226SKB315SKB315SKB3151a1/2 SKB315 SKB410 (MK-3120) SKB410Nectin-4 ADCSKB410(PK)FDAADCSKB410 202212ADCSKB410SKB410 20232SKB410IND1a SKB410 A167 A167PD-L1PD-L1PD-L1PD-1PD-(L)11LPD-(L)1PD-(L)1 A167ADC (RM-NPC)A1672A167SKB264A167 202111NDA2024A167RM-NPC3LA1671LRM-NPC3A167ADC2SKB264A167EGFRNSCLC1L2SKB264A167TNBCHR+/HER2-BC1L2 20188Harbour BioMedA167 A167 A140 A140EGFR(RAS)(mCRC)(RM-HNSCC)(LA-HNSCC) 20239A140RASmCRCHNSCC NDANDA A140 A400 A400(RET)RET+RET 2%RETA400NSCLC(MTC)20231231RETRET+RETRETA400RET 20213EllipsesA400 A400RET+ NSCLCA4001L2L+RET+NSCLC2024RET+ NSCLCNDA20226A400INDFDA202311A400FDARET20243A400FDARETNSCLC A40012023652023ASCORETA400RET1/21L2LRETNSCLCORR80.8%69.7%DCR96% A400 A296 A296(STING)(ICI) IND1A2961 A296 (RA)(AA)(CKD)(CKD-aP) A223 A223Janus12 (JAK1/2)AARA A223JAK2A223RA122 mgA22320(ACR20)35.1%63.6%28.6%50(ACR50)33.7%39.4%5.7% RA2A223AAOlumiant®Litfulo®FDAAA20231231AA2 A223 A277 A277CKD-aPκ(KOR)CKD-aP20231231CKD-aP A277KORKORmu(MOR)A277CNSKORKORA2771bCKD-aPA277A277CKD-aP 2 A277 SKB378 SKB378(TSLP)SKB378TSLPTSLP22TSLPTSLP 250%TSLPTSLP IND202221 SKB378 SKB336 SKB336XI(FXI)/Xia(FXIa)(TKA)(VTE)20231231FXI/FXIaSKB336FXI/FXIa FXI/FXIaFXI/FXIaFXI/FXIaTKAVTE IND202171 SKB336 ADC